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Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System

Study acronym: ANTHEM PS
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv17
  2. Phase: Not applicable to Not specified
    • Site details revised at 2 of 8 sites
    v16
  3. Primary completion date: Sep 25, 2029 to Apr 30, 2029
    • Study completion date: Dec 30, 2029 to Apr 30, 2029
    v15
  4. Primary completion date: Dec 30, 2028 to Sep 25, 2029v14
  5. Study sites: 7 to 8v13
Show 11 earlier versionsHide 11 earlier versions
  1. 3 versions Re-verified since Aug 2, 2021, no change to tracked fieldsv10-v12
  2. Study sites: 8 to 7v9 Show 4 more changesShow less
    • Interventions: ANTHEM™ Total Knee System implant (Device) to ANTHEM™ PS Total Knee System implant (Device)
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 2 words
    • Study title expanded, about 1 word
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 143 to confirmed 148
    • Site details revised at 8 of 8 sites
    v8
  4. Enrollment target: 196 to 143
    • Study sites: 6 to 8
    • Study description revised
    v7
  5. Site details revised at 4 of 6 sitesv6
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 30, 2017 to Jun 28, 2017
    • Site details revised at 6 of 6 sites
    v5
  7. Start date: May 30, 2017 to Jun 30, 2017v4
  8. Start date: Apr 10, 2017 to May 30, 2017
    • Site details revised at 2 of 6 sites
    v3
  9. Secondary endpoints: details revised at 1 of 7 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
Trial Details
NCT Number NCT03078543
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Arthroplasty, Replacement, Knee
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov